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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
ClinicalTrials.gov ID: NCT06910722
What this study is testing
- What it's testing
- The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma. It is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patient aged 18 to 65
- With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
- Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))
- Without extrahepatic or lymph node involvement
- Technically unresectable R0 according to an expert panel
You likely can't join if
- Extrahepatic, vesicular or perihilar cholangiocarcinoma
- Tumor infiltration of more than 50% of the liver
- Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
- Previous treatment for CCI
- Cirrhosis ≥ Child B7
- Chronic alcoholism
See the full eligibility criteria
- Patient aged 18 to 65
- With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
- Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))
- Without extrahepatic or lymph node involvement
- Technically unresectable R0 according to an expert panel
- Tumor target \> 2 cm
- WHO 0-1
- free and informed consent signed
- highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH
- Extrahepatic, vesicular or perihilar cholangiocarcinoma
- Tumor infiltration of more than 50% of the liver
- Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
- Previous treatment for CCI
- Cirrhosis ≥ Child B7
- Chronic alcoholism
- Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)
- Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml/min)
- Contraindications to liver transplant
- Severe untreatable conditions
- Recent history (less than 5 years) of cancer
- severe comorbidities
- Psychiatric or psychological disorders
- Pregnant or breast-feeding women
- Patient under guardianship
- Not affiliated to a Health care system
- Participating in another treatment study or within the exclusion period of a previous study involving the human body
The study team makes the final eligibility decision.
Where it's taking place
- Clichy-sous-Bois, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy-sous-Bois, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.